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Legal- and ethical considerations for the off-label use of healthcare products

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Within the South African context, the use of medicines and medical devices contrary to the labels of such products, raise various legal- and ethical issues.

Medical device regulation in South Africa

Medical devices include all health products defined as such in the Medicines and Related Substances Act of 1965 (Medicines Act). Section 1 defines medical devices as related to its intention by its manufacturer, to be use for one or more...

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